Condition category
Circulatory System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R. Ouwendijk

ORCID ID

Contact details

Department of Radiology
ErasmusMedical Center Rotterdam
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
r.ouwendijk@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

Acronym

DIPAD trial

Study hypothesis

Is the diagnostic imaging workup of patients with peripheral arterial disease performed initially with Magnetic Resonance (MR) angiography cost-effective compared to the currently employed workup with duplex ultrasound or Computed Tomography (CT) angiography?

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Peripheral Arterial Disease (PAD)

Intervention

1. Magnetic resonance angiography: requires intravenous contrast material injection and duration of the examination is 30 minutes
2. Duplex ultrasound: requires no intravenous contrast material injection and duration of the examination is variable
3. Computed tomographic angiography: requires intravenous contrast material injection and duration of the examination is 10 minutes

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcomes evaluated were quality of life and costs.

Secondary outcome measures

Secondary outcomes evaluated were clinical utility and functional patient outcomes.

Overall trial start date

01/12/2001

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women at least 18 years old
2. Symptomatic Peripheral Arterial Disease (PAD)
3. An ankle-brachial index less than 0.90
4. Referred from the Department of Vascular Surgery for a diagnostic imaging workup to evaluate the feasibility of a revascularisation procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

514

Participant exclusion criteria

1. Contraindications for MR angiography (e.g., pacemaker, cerebral vessel clipping, or claustrophobia) or CT angiography (e.g., severe renal insufficiency or adverse reactions to iodinated contrast agent)
2. Need an acute intervention at time of randomisation

Recruitment start date

01/12/2001

Recruitment end date

01/10/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Radiology
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16020559
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16020559
3. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16864668

Publication citations

  1. Ouwendijk R, de Vries M, Pattynama PM, van Sambeek MR, de Haan MW, Stijnen T, van Engelshoven JM, Hunink MG, Imaging peripheral arterial disease: a randomized controlled trial comparing contrast-enhanced MR angiography and multi-detector row CT angiography., Radiology, 2005, 236, 3, 1094-1103, doi: 10.1148/radiol.2363041140.

  2. de Vries M, Ouwendijk R, Flobbe K, Nelemans PJ, Kessels AG, Schurink GH, van der Vliet JA, Heijstraten FM, Cuypers PW, Duijm LE, van Engelshoven JM, Hunink MG, de Haan MW, Peripheral arterial disease: clinical and cost comparisons between duplex US and contrast-enhanced MR angiography--a multicenter randomized trial., Radiology, 2006, 240, 2, 401-410, doi: 10.1148/radiol.2402050223.

Additional files

Editorial Notes